PROFNAIT
Development of a prophylactic treatment for the prevention of fetal/neonatal alloimmune thrombocytopenia (FNAIT)
| Coordinatore | PROPHYLIX PHARMA AS
Organization address
address: SYKEHUSVEGEN 23 FORSKNINGSPARKEN contact info |
| Nazionalità Coordinatore | Norway [NO] |
| Totale costo | 7˙837˙467 € |
| EC contributo | 5˙986˙000 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2012-INNOVATION-1 |
| Funding Scheme | CP-FP |
| Anno di inizio | 2012 |
| Periodo (anno-mese-giorno) | 2012-08-01 - 2018-07-31 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
PROPHYLIX PHARMA AS
Organization address
address: SYKEHUSVEGEN 23 FORSKNINGSPARKEN contact info |
NO (TROMSO) | coordinator | 2˙719˙082.60 |
| 2 |
LARIX AS
Organization address
address: TEMPOVEJ 44 - 1st floor contact info |
DK (BALLERUP) | participant | 709˙737.24 |
| 3 |
UNIVERSITETSSYKEHUSET NORD-NORGE HF
Organization address
address: SYKEHUSVEIEN 38 contact info |
NO (TROMSO) | participant | 585˙193.06 |
| 4 |
DRK-BLUTSPENDEDIENST BADEN-WURTTEMBERG-HESSEN GGMBH
Organization address
address: FRIEDRICH EBERT STRASSE 107 contact info |
DE (MANNHEIM) | participant | 553˙903.20 |
| 5 |
FRAUNHOFER-GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V
Organization address
address: Hansastrasse 27C contact info |
DE (MUENCHEN) | participant | 517˙905.70 |
| 6 |
STOCKHOLMS LAENS LANDSTING
Organization address
address: Hantverkargatan 45 contact info |
SE (STOCKHOLM) | participant | 287˙401.44 |
| 7 |
OSLO UNIVERSITETSSYKEHUS HF
Organization address
address: FORSKNINGSVEIEN 2B contact info |
NO (OSLO) | participant | 237˙439.22 |
| 8 |
LUNDS UNIVERSITET
Organization address
address: Paradisgatan 5c contact info |
SE (LUND) | participant | 165˙613.26 |
| 9 |
UNIVERSITETET I TROMSOE
Organization address
address: Hansine Hansens veg 14 contact info |
NO (TROMSO) | participant | 108˙326.40 |
| 10 |
REGION NORDJYLLAND (NORTH DENMARK REGION)
Organization address
address: Niels Bohrs Vej 30 contact info |
DK (AALBORG) | participant | 78˙389.98 |
| 11 |
SKANE LANS LANDSTING
Organization address
city: KRISTIANSTAD contact info |
SE (KRISTIANSTAD) | participant | 18˙900.00 |
| 12 |
BIOTEST AG
Organization address
address: LANDSTEINER STRASSE 5 contact info |
DE (DREIEICH) | participant | 4˙107.09 |
Mappa
Word cloud
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Obiettivo del progetto (Objective)
'Objective--The project aims to develop an anti HPA-1a immunoglobulin (IgG), Tromplate® that can prevent post delivery immunisation of the mother against the Human Platelet Antigen-1a (HPA-1a). This prophylactic treatment will prevent Fetal/Neonatal Alloimmune Thrombocytopenia (FNAIT) in the fetus/newborn in subsequent pregnancies. FNAIT--FNAIT is a rare but potentially serious condition which affects about 4,000 fetuses and newborns a year in EU-27 and which may result in severe bleeding, intracranial hemorrhage, fetal death or lifelong disability. FNAIT may develop when the mother and the fetus have different platelet surface antigens, most commonly HPA-1a. Transferral of HPA-1a antigen from the fetus may cause immunisation of the mother and the anti-HPA-1a antibodies she develops may in turn destroy the platelets of subsequent HPA-1a positive fetuses/newborns and cause FNAIT. Today, no good treatment of FNAIT exists. Rationale--Previously, it was believed that the pregnant woman develops antibodies early in the first pregnancy with the implication that FNAIT could not be prevented. However, a study conducted by the applicants of more than 100,000 pregnancies revealed that HPA-1a antibody formation most often takes place in association with or after delivery. Therefore, anti-HPA-1a IgG given to the mother shortly after birth should prevent her immune system from generating harmful anti-HPA-1a antibodies. This concept is analogous to the use of anti(D) for Rhesus D prophylaxis. Activities--The project elements: manufacturing of Tromplate® using the process for producing anti(D); screening for HPA-1a negative and pregnant women and clinical Phase II/III studies investigating the efficacy and safety of Tromplate®. Relevance to the work program−The prophylactic Tromplate® treatment has obtained orphan drug status in Europe. FNAIT represents a significant health care expense for the society and a great burden for the affected children and their families.'
Introduzione (Teaser)
Immunoglobulins are emerging as a safe and efficacious approach for preventing female immunisation by an antigen from her foetus. European scientists are screening such a strategy for a rare immune-mediated condition.